Standing Committee G

[Mr. Alan Hurst in the Chair]

Human Tissue Bill

Clause 3 - ''Appropriate consent'': adults

Amendment proposed [this day]: No. 90, in 
clause 3, page 3, line 40, at end insert— 
 '(2A) In relation to the purposes in paragraph 7 in Schedule 1, where it is not contrary to his interests and would benefit persons with the same or similar conditions, a person who stands in a qualifying relation to him can consent on behalf of an adult who lacks the mental capacity to make decisions on his own behalf.'.—[Mr. Lansley.]
 Question again proposed, That the amendment be made.

Alan Hurst: I remind the Committee that with this we are discussing the following:
 Amendment (a) to the proposed amendment, in 
line 1, leave out 'paragraph' and insert 'paragraphs 3, 5 and'.
 Amendment (b) to the proposed amendment, in 
line 2, leave out 'would' and insert 'might'.
 Amendment No. 91, in 
clause 24, page 15, line 24, after '(ii)', insert '3(2A)'.

Evan Harris: When we adjourned, I was explaining why I think that there is some merit in including further purposes in paragraphs 3 and 5 to enable those who lack capacity to participate in research. If one relies only on best interest, it is difficult to argue that material from such people can be used, because it is harder to prove that that would be in their best interest. The test of whether it is not contrary to their best interest is more valid.
 I was about explain briefly that patients with a ruptured aneurysm in their head are usually, but not always, in a pretty bad way and unconscious, and may proceed to acute surgery when samples may be taken. Those samples might be useful for research on the cause and treatment of, as well as the inflammatory response to, such aneurysms. 
 It is not clear whether such tissue may be stored for the purposes of research to await any recovery of the patient. Sadly, people with such a serious condition sometimes do not recover and there may be a particular interest in looking at the material for research purposes rather than for treatment or diagnosis in such cases. It is likely, but not certain, that there may eventually be benefits for similar patients. 
 I could give other examples involving more chronic incapacity—it would be sad if the Bill failed to take account of that. The Government may intend to amend the Bill through other legislation covering incapacity. The hon. Member for South 
 Cambridgeshire (Mr. Lansley) and I may find that satisfactory, but it should be clarified. 
 My amendment (b) would clarify amendment No. 90. It proposes words that are a little less specific than ''would benefit persons''—we are in the realms of future research—and would to change them to 
''might benefit persons with the same or similar conditions''.
 It is not against the interests of an incapacitated person for their tissue, with appropriate consent from an appropriate person, to be subject to research when there is a chance, although not a certainty, that that might benefit people with the same or similar conditions. 
 The same extension could be made for education and training, because it will be difficult to obtain material for clinicians' education and training, which will aid future treatment and cures, if samples from such patients are never available for the purposes of paragraph 3 of schedule 1. I wait with interest to hear the Minister's response.

Rosie Winterton: I understand the contributions of the hon. Member for South Cambridgeshire, my hon. Friend the Member for Leyton and Wanstead (Harry Cohen)—he made valid comments not only about people with mental incapacity, but about people with mental illness—and the hon. Member for Oxford, West and Abingdon (Dr. Harris).
 Perhaps I may say first to my hon. Friend that it is important to be clear that people may have a mental illness, without losing capacity, but be able to make decisions. We are looking particularly at the issue of people who are mentally incapacitated and we must distinguish between the two. 
 Under common law, nobody can consent to medical procedures on behalf of a mentally incompetent adult, although treatment can be carried out if it is necessary and in the person's best interests. A person without capacity to give consent will not be able to provide the necessary consent for the use of their material for the purposes listed in the Bill, including research. When such a person dies, their relatives will be able to consent to their body, or material from it, being used. 
 The Mental Incapacity Bill covers questions of consent on behalf of incapacitated persons. The Bill has recently undergone pre-legislative scrutiny, and we will consider any changes that have to be made to the common law position. If changes have to be made to this Bill as a result, they will be made through the relevant channel.

Andrew Lansley: I am grateful to the Minister for at least making clear what I suppose we had expected, but she does not say what the Government's intentions are. In advance of legislation that covers the whole field, it may be premature to ask them to state their intentions in relation to the important aspect of consent for mentally incapacitated persons, but that means that we will not be able to consider the issue in the context of the Bill.
 Although we hope that the Bill will in due course become the Human Tissue Act and that it may be amended, there will be a time during which the review process has clearly failed to complete its course in this significant respect. Those of us who are focusing on the provisions in the Bill may not have the opportunity to give future amendments the same scrutiny. 
 There is little scope for us to press the Government further, when they consider themselves procedurally, if not constitutionally, constrained from being able to say more. On that basis, I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn.

Richard Taylor: I beg to move amendment No. 51, in
clause 3, page 3, line 41, at beginning insert 
 'Except where subsection (3A) applies'.

Alan Hurst: With this it will be convenient to discuss the following amendments:
 No. 52, in 
clause 3, page 3, line 43, at end insert— 
 '(3A) Where the person concerned has died and no person in a qualifying relationship can be found or the person cannot be identified, ''appropriate consent'' means the consent of the coroner.'.
 No. 73, in 
clause 3, page 4, line 23, at end insert— 
 '(d) if neither paragraph (a) nor paragraph (b) applies and no person who stood in a qualifying relationship to him immediately before he died exists or can be found in a reasonable time, the hospital authority.'.
 No. 74, in 
clause 3, page 4, line 23, at end insert— 
 '(5A) Where the person concerned has died and the activity does not involve storage for use, or use, for the purpose of anatomical examination or public display and the person concerned cannot be identified, ''appropriate consent'' means the consent of the coroner.'.

Richard Taylor: I am afraid that I must start by craving your indulgence, Mr. Hurst. When I was penetrating the tortuous depths of the Bill, to meet the deadline for tabling amendments, I had not reached the striking clarity of clause 56, so I framed amendment No. 51 under the misunderstanding that an anatomical examination implied post mortem examination. With your indulgence, may I ask the Minister to clarify some matters regarding post mortem examination, which are not clear in the Bill?
 My problem arises from my experience as a practising physician. A patient, perhaps one whom I had known for years, might die from a rare, puzzling illness, but one would find that they had no relatives. A medical value post mortem—to use the phrase ''medical interest'' would be wrong—was crucial to confirm the diagnosis, see the effect of treatment and demonstrate a unique case for teaching purposes. As far as I can see, the Bill does not contain any provision for a request for a post mortem when no family can be found. The point of the amendment is to find out whether that is the case.

Evan Harris: I rise to speak to amendments Nos. 73 and 74, which probe on an issue separate from but
 analogous to the framing of the amendments tabled by the hon. Member for Wyre Forest (Dr. Taylor). They deal with what happens when there are no relatives available from whom consent can be obtained, the subsequent position on organ donation and what happens when a person is unidentifiable.
 Amendment No. 73 states that 
''if neither paragraph (a) nor paragraph (b) applies and no person who stood in a qualifying relationship to him immediately before he died exists or can be found in a reasonable time, the hospital authority''
 would be the appropriate body to decide whether organs could be used. Under the Human Tissue Act 1961, those lawfully in possession of the body are able, though not required, of course, to use organs for transplantation if the person consented or if there is no reason to believe that they did not. The debate has long been about who has lawful possession of the body. 
 The Bill clarifies many matters, but it still does not deal with someone who is identified and is known to have no family, friends or reachable friends who would fit the qualifying relationship. Will the Minister provide clarification on whether hospital authorities can use organs—for transplantation, for example—or absolutely cannot? 
 Amendment No. 74 would add proposed subsection (5A). I am not certain of the circumstances in which the terms of the amendment would be appropriate. If someone were unidentified, it might be difficult for the purposes of transplantation to be certain that there were not unknown medical contra-indications. It would be useful to clarify the appropriate consent, if any might exist, in those circumstances.

Andrew Murrison: I am glad that the hon. Member for Wyre Forest has clarified his intentions, because I was going to condemn him as a resurrectionist, given how his amendment reads. Clearly, he is not one. I am relieved to know that individuals will not be anatomised and dissected in medical schools at the behest of the coroner, because that would be inappropriate.
 I understand that, if cause of death cannot be certified, which was a concern of the hon. Gentleman, it would be, de facto, a coroner's case. We would not therefore need the separate permission of the coroner to undertake a hospital post mortem, because establishing the cause of death would proceed as a coroner's case. 
 If one does not know the cause of death, it is sadly quite likely that the person will not have any friends or relatives. We can all think of cases in which people who have died were of no fixed abode and without friends. One does not know why, and one would like to know more about the death. It would be good to have a hospital post mortem, as, having established the bare facts of the cause of death, one would like to know more. 
 Tempting though such a proposal may be, we have to resist it, on the basis that it would not be essential to do a hospital post-mortem in that case, because, 
 presumably, the cause of death would have been established. If it had not, it would be a coroner's case. In such rare instances, we must protect the rights of the individual who has not consented to a post-mortem and has no friends or relatives who could do so under the Bill. Regrettably, therefore, we cannot support the proposal, tempting though I find it as someone who has faced that dilemma professionally. 
 Amendment No. 73 mirrors the revised amendments No. 51 and 52, tabled by the hon. Member for Wyre Forest. Unless I am very much mistaken, the clarification given by the hon. Member for Oxford, West and Abingdon means that the amendments are similar. I am intrigued by the non-identifiable person referred to in amendment No. 74. Like the hon. Gentleman, I struggle to think of instances where it might apply, but I am sure that he has thought of some. In short, that is enough from me. I look forward to hearing the Minister's clarification of the matters arising.

Rosie Winterton: We generally agree that, as the hon. Member for Westbury (Dr. Murrison) said, the amendments tabled by the hon. Member for Wyre Forest are related more to post-mortem than to either anatomical examination or public display. There is general consensus that that would not be appropriate.
 The amendment tabled by the hon. Member for Oxford, West and Abingdon would give a hospital authority the power to delay transplantation of organs from a person who has far-flung relatives, and it would give the coroner the power to do the same in relation to an unidentified body. The issue, once again, is that the whole Bill is based on the need for informed consent. There must be respect for the rights of the individual. The simple fact that it is impossible to find out what an individual's wishes would have been does not mean that we should override those rights. I agree with the hon. Member for Westbury that it is a question of individual rights. 
 The policy encapsulated in the Bill was arrived at after public consultation. The key is that consent from the individual or a person close to the deceased must be given if use of their bodies or tissue is to be lawful. As I said, the bodies of the deceased do not belong to the state or the medical profession. We certainly have no intention of allowing third parties, who have no close connection to the deceased, to make decisions about using bodies for education, research or transplantation. 
 It follows that when a deceased person cannot be identified, or his relatives found, his body and material from it may not be used for the purposes regulated by the Bill. If a person dies and no relatives or close friends can be found, the coroner is be allowed to order a post-mortem to confirm the cause of death, but the principle would apply that any material from that post-mortem would not be used for other purposes because the person's consent had not been given. I hope that I have clearly set out the Government's position. We cannot accept the amendment, and I hope that it will be withdrawn.

Richard Taylor: The Minister has not quite answered my specific question. I shall try to explain. As a hospital
 physician, one gives the death certificate because one perfectly well knows the cause of death. From the point of view of my own learning and experience of teaching student junior doctors, a post-mortem on that patient would be very helpful.

Rosie Winterton: As I have said, because consent is required from the nearest relative for a post-mortem in those circumstances, one that would not be allowed under the Bill.

Richard Taylor: I thank the Minister for making that crystal clear. I have no alternative but to beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn.

Evan Harris: I beg to move amendment No. 141, in
clause 3, page 4, line 11, leave out 'or public display' and insert 
 ', public display or transplantation following removal in accordance with the provisions of section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation]'.

Alan Hurst: With this it will be convenient to discuss the following:
 Amendment No. 142, in 
clause 3, page 4, line 23, at end insert— 
 '(5A) Where the person concerned has died and the activity involves storage for use, or use, for the purpose of transplantation following removal in accordance with the provisions of section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation], ''appropriate consent'' means consent determined in accordance with the provisions of that section.'.
 Amendment No. 143, in 
clause 23, page 14, line 22, leave out paragraph (d) and insert— 
 '(d) the definitions of death for the purposes of this Act, including a definition of death confirmed by brain stem tests for the purpose of section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation]; 
 (dd) the procedures to be followed in relation to brain stem tests for the purpose of confirming death;'.
 Amendment No. 76, in 
clause 23, page 14, line 22, leave out paragraph (d).
 New clause 3—Determination of consent for removal, storage and use of organs from adults for purpose of transplantation— 
'(1) Where part of a body of an adult lying in a hospital or other institution is or may be suitable for use for transplantation, it shall be the duty of the person having the control and management of the institution to ensure that, before any organ is removed from the body, each of the conditions specified in subsection (2) is met. 
 (2) Those conditions are— 
 (a) that the deceased was, immediately before he died, ordinarily resident in England, Wales or Northern Ireland; 
 (b) that, where the person to whom the duty under subsection (1) applies knows, or has reason to believe, that— 
 (i) the body of the deceased person, or 
 (ii) relevant material which has come from the body of a deceased person, 
 is, or may be, required for purposes of functions of a coroner, the consent of the coroner has been obtained; 
 (c) that the deceased had not opted to make his organs, or the relevant organ, unavailable for removal for the purpose of transplantation and recorded that view in the register maintained in accordance with the provisions of section [register of persons opting to make organs unavailable for removal for purpose of transplantation]; and 
 (d) that no person with a right to signify an objection under the provisions of section [duties in relation to persons who stood in a qualifying relationship] has done so. 
 (3) Where each condition in subsection (2) is met, consent shall have been determined for— 
 (a) the removal of organs, or the relevant organ, for the purpose of transplantation, and 
 (b) for the subsequent storage for use, and use, of such organs for the purpose of transplantation. 
 (4) Where a body is transferred to another institution prior to the removal of any organ, the duty under subsection (1) shall also be transferred to the person having the control and management of the institution to which the body has been transferred. 
 (5) In dealing under section 23(1) with the matters mentioned in this section and sections [register of persons opting to make organs unavailable for removal for purpose of transplantation] and [duties in relation to persons who stood in a qualifying relationship], the Authority shall, in particular, lay down the standards expected in relation to the performance of the duty imposed by subsection (1). 
 (6) In this section and sections [register of persons opting to make organs unavailable for removal for purpose of transplantation] and [duties in relation to persons who stood in a qualifying relationship]— 
 ''death'' has the meaning given in accordance with the provisions of section 23(2)(d); and 
 ''organ'' means any part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body.'.
 New clause 4—Register of persons opting to make organs unavailable for removal for purpose of transplantation— 
'(1) It shall be the duty of the Authority to maintain a register of persons opting to make all their organs, or specified organs, unavailable for removal for the purpose of transplantation. 
 (2) Any person who opts to make all his organs, or specified organs, unavailable for removal for the purpose of tranplantation may inform the Authority in a prescribed manner. 
 (3) Any person who has informed the Authority of his decision under subsection (2) but then opts to make all his organs, or specified organs, available for removal for the purpose of transplantation may inform the Authority in a prescribed manner. 
 (4) Upon receipt of information in accordance with subsection (2) or (3) the Authority shall— 
 (a) confirm to the relevant person in writing that the information has been received, and 
 (b) ensure that— 
 (i) an appropriate entry is made in, or removed from, the register, or 
 (ii) the appropriate entry is amended. 
 (5) The Secretary of State may by regulations prescribe the ways in which an adult may provide information to the Authority for the purposes of this section, including opportunities to provide such information when a person is— 
 (a) applying for a driving licence, 
 (b) making an application for a passport, or 
 (c) providing information relating to the register of parliamentary or local government electors. 
 (6) The Authority shall take such steps as it considers appropriate to promote public awareness of the register and of the means by which a person may make an entry in the register. 
 (7) Where the Authority is satisfied that— 
 (a) a person in relation to whom information is held on the register has died, and 
 (b) a period of one month has elapsed since his death, 
 the Authority may remove the entry in respect of that person from the register. 
 (8) Information held by the Authority in accordance with the provisions of this section may only be made available to— 
 (a) the person in respect of whom the information is held, and 
 (b) a person to whom the duty under section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation] applies. 
 (9) A person commits an offence if he— 
 (a) makes information held by the Authority in accordance with the provisions of this section available other than to the persons specified in subsection (8), 
 (b) does anything which causes an entry— 
 (i) not to be made in the register after the Authority has been informed in a prescribed manner, 
 (ii) to be removed without due authorisation, or 
 (iii) to be false or incomplete. 
 (10) A person guilty of an offence under subsection (9) shall be liable to— 
 (a) imprisonment for a term not exceeding 12 months, or 
 (b) a fine not exceeding the statutory maximum, or 
 (c) both.'.
 New clause 5—Duties in relation to persons who stood in a qualifying relationship— 
'(1) It shall be the duty of the person to whom the duty under section [determination of consent for removal, storage and use of organs from adults for purpose of transplantation] applies to— 
 (a) inform the person or persons who stood in a qualifying relationship to the deceased immediately before the death of the deceased of his rights under this section, and 
 (b) to provide him or them with an opportunity to exercise those rights. 
 (2) Those rights are— 
 (a) to be informed about the operation of relevant provisions of this Act, and 
 (b) to signify an objection to the removal of a relevant organ for a reason specified in subsections (3) to (5). 
 (3) The reason specified in this subsection is that the deceased person had expressed his wish to make all his organs, or a relevant organ, unavailable for removal for the purpose of transplantation even though he had not informed the Authority for the purpose of the making of an entry in the register. 
 (4) The reason specified in this subsection is that— 
 (a) the deceased person had expressed his wish to make all his organs, or a relevant organ, unavailable for removal for the purpose of transplantation, and 
 (b) he had informed the Authority accordingly, but 
 (c) a relevant entry had not been made in the register. 
 (5) The reason specified in this subsection is that the removal of a relevant organ for the purpose of transplantation would cause significant distress to any person who stood in a qualifying relationship to the deceased immediately before his death. 
 (6) The qualifying relationships for the purposes of this section are— 
 (a) spouse or partner; 
 (b) parent or child; 
 (c) brother or sister. 
 (7) The qualifying relationships shall be ranked in the order given in subsection (6) for the purposes of subsection (1). 
 (8) Relationships in the same paragraph of subsection (6) shall be accorded equal ranking for those purposes. 
 (9) The duty under subsection (1) shall apply in relation to the person or persons whose relationship to the person who has died is accorded the highest ranking in accordance with subsections (6) to (8). 
 (10) If two or more persons are accorded equal ranking in accordance with subsections (6) to (8), the duty under subsection (1) shall apply to all of the persons accorded that ranking. 
 (11) In applying the principles set out above for the purposes of subsection (1), a person's relationship shall be left out of account if— 
 (a) he does not wish to exercise his rights under this section, 
 (b) he is not able to exercise those rights, or 
 (c) it is not reasonably practicable to communicate with him within the time available before the organ or organs must be removed.'.

Evan Harris: This is a substantial group of amendments, but I am conscious of the pressure of time since I know that we want to make progress—I as much as anyone—which is why I am happy to limit my contribution to about seven minutes. The Minister may well have a lot to say, but perhaps it would be best to debate specific issues through interventions rather than my setting out something that we may wish to repeat at a later date, while other people who support the opt-out of presumed consent are able to put their names to an amendment at a later stage.
 To cut things short, I am keen to stress that the amendment is designed to do several things. Using an opt-out system and a presumption of consent for adults where there has not been an opt-out would lead to a greater rate of organ donation with the subsequent downstream effects of a greater prevention of avoidable loss of life, and avoidable morbidity through transplantation. There is strong evidence that that would be the impact. 
 There has been a series of reviews in the literature, and I have conducted an exhaustive search for published reviews to see whether there are suggestions that such a system does not work. Reviews have shown that there is felt to be a significant impact on the number of organs made available, when controlling for other factors, which is sometimes difficult to do. Given the state of play—increasing waiting lists and significant numbers of people dying while waiting—and, despite the best efforts of the Government, clinicians, UK Transplant and officials, all of whom I fully support, we face a worsening position, especially with regard to cadaveric donors. That is likely to continue for some years to come. 
 I was surprised that the Department said in a press release that there was no evidence to support the proposition that the process would work, because it has worked in other countries where it has been tried. A review by Professor Kennedy of the European Forum for Transplant Ethics and a recent review by researchers in New York covering the piste of European systems showed that there had been a significant effect. In the interests of speeding things up, I shall not read out the conclusions.

Andrew Murrison: To which countries is the hon. Gentleman referring, and which countries, having tried it, maintain the opt-out system that he is describing?

Evan Harris: I am happy to send the hon. Gentleman the references. I tend to refer to the Belgian model, but many countries were considered. Consideration was given not only to their legislation but to their practice,
 and the reviewers concluded that there was a significant impact. In fact, even where a very soft system of presumed consent was practised, it was felt that having the legislation in place had an impact, because it changed the mindset.
 It is not sufficient to consider the evidence for beneficial downstream effects, because there are other hurdles to jump. One must demonstrate that the system would be more likely to meet the wishes of the donor, because I agree that the wishes of the donor should be primary. There is increasing evidence that our current system, under which we ask relatives to second-guess the wishes of their loved ones, makes it difficult for those wishes to be acceded to. Opinion poll and survey data consistently show that between 70 and 90 per cent. of people are willing to become donors when they die, but only 50 per cent. of relatives give consent. Some 48 per cent. say no, according to the latest survey, which was carried out by UK Transplant. 
 That gap is significant. People who are willing to donate are not enabled to do that, because relatives, at the height of their grief, are asked, ''What do you think your loved one would have wanted? And if you haven't a clue, what do you think?'' That is not the best way to ensure that the donor's wishes are primary. Until we get a full opt-in system under which knowledge is available to relatives, we will still have the problem of that gap. We are still a long way away from that system.

Ian Lucas: Will the hon. Gentleman clarify a point for me? Is he talking about cases in which the deceased has indicated consent, or cases in which there is no evidence whether the deceased has indicated consent?

Evan Harris: Under the current system, relatives are sometimes approached in the knowledge that there is a donor card and an indication on the organ donor register. It is hard to tease things out, but, if we take a proportionate approach, about 15 per cent. of people have been on the organ donor register over the past few years. Assuming that the register is checkable and checked, a proportion of relatives will be in the situation referred to. However, we heard earlier that there are cases in which that is not sufficient and relatives say that because of their own objections that they do not want donations to be made. That situation is difficult.
 Under a system of presumed consent, if relatives were to volunteer an objection, the system would work in a similar way to the present system. Under the system that I propose, if relatives volunteer that they would be distressed—they are usually asked specifically, which is a questionable practice—the organs would not be taken. That is what makes it a soft, not a hard, system. 
 Between September and December 2003, there were 11 cases in which people who were on the organ donor register did not have their organs used. On the assumption that that was down to relatives withholding consent—the reason why the majority of organs are not taken—that suggests that the problem 
 is somewhat greater than the figure of 1 per cent. would suggest.

Ian Lucas: In some of those 11 cases, could the reason not be completely different? Might it be that families would not give consent for removing organs from the deceased. A body may have been HIV-positive, for example.

Evan Harris: That is certainly possible, and we need to tease out the data. In fact, I am on the hon. Gentleman's side. If it is the case that where there is a presumption, whether through an opt-in or an opt-out system, that someone is willing for their organs to be used—the 70 to 90 per cent. of cases—and if it is true that relatives rarely object to or veto the decision, an opt-out system with presumed consent and a relative check is very effective. If the hon. Gentleman and the Minister are right—I hope that they are—that there is no new phenomenon of relatives saying that they will be distressed, despite the presumed or actual consent granted by the patient, the opt-out system will work effectively. Softening the system—I think that that was the term used by the hon. Member for Westbury—would cater for the minority of cases where relatives had specific concerns. The purpose of such a scheme is to ensure that we maximise the number of times that the organ donor's wishes are met—their wishes expressed by not opting out—and clearly there must be adequate opportunities to do that. Research shows that that is optimised.
 We must ensure that ethics experts do not deem it unethical to use a system of opt-out and then presume the consent of those who have not opted out. The view across Europe is that it is not unethical. Some countries such as ours have chosen not to go down that path, and others have chosen to do so, but no pan-European organisation has expressed the view that it is unethical. Indeed, the view of many ethical authorities in this country is that it is ethical.

Andrew Murrison: I am grateful to the hon. Gentleman for giving way on a similar point to the one that I raised with him earlier, which relates to the countries in Europe that operate the opt-out system. May I press him to tell the Committee in broad terms the number of countries in Europe where the opt-out system operates and the number where it does not? That would be helpful.

Evan Harris: I am keen to get on, and there will be other opportunities to discuss specific country examples. I want talk about the proposal in broad terms, but I shall send the hon. Gentleman the references from the reviews.
 A number of ethical authorities in this country believe that, because of the pressing need for organs, it is not only ethical but ethically right to opt out. Many people are dying while waiting for an organ and a number of organs are lost whose donors would have wanted them to be used in such a way. I am more than willing to cite those authorities. 
 Much in the Bill and our debates has dealt with the way in which we should treat relatives. I need to explain how an opt-out system would work, although it is described in the new clauses. The system would apply only to adults and to people ordinarily resident in this country, so it would not apply to people from overseas who may not know the system. The detail would be determined in any plan, but people would have the opportunity to opt out through post offices, driving licence and passport applications, at GP registration or in communications relating to the electoral roll requirement, although a legislative change may be necessary to maximise that potential. Therefore, there would be multiple opportunities to opt out and plenty of opportunities for people to discuss the issue with their families in a way that, sadly, despite all the efforts of educators and advocates, does not occur at present because so many relatives do not know their loved one's wishes. 
 Where someone has chosen not to exercise the opt-out—this could run parallel with a donor card system—the presumption would be that they have no objection to their organs being used to save the life of someone else after their death. We propose a soft system of presumed consent, where the relatives are approached in the same way as they are now, asked the necessary questions about medical and social history—to say that that must still be done is not an argument against the system—and informed that no opt-out has been found on the opt-out register. They would then be asked whether they knew of any opt-out that had not been registered—if that had been discussed and the person concerned had said that they did object, but had not got round to opting out. That is critical. If relatives said that such a situation existed, it would be taken as an opt-out. 
 Furthermore, if at that stage the relatives volunteered that they would suffer significant distress, despite there being no opt-out on the register and no known opt-out from the person—or, indeed, as now, if the person had been quite keen on the idea of donation—organs would still not be taken. That accepts the Minister's point in our earlier debate that, practically, it is not good policy to take organs in those circumstances. I was pleased that I was able to press her on that matter because every one of her answers—she said how important it was that where there was significant distress, organs should not be taken—was acceptable to me, and I was able to cite them in describing the new clauses that would introduce such a system.

Ian Lucas: Who assesses significant distress?

Evan Harris: The same people who assess it at the moment. The problem would not change if we moved from an opt-in to an opt-out system. When there is donor card, for example, doctors must judge without necessarily having to press the relatives whether it would be too distressing to push the point. I have been in that position as a practitioner. I have known situations where patients were dying for want of an organ, and where it was clear that the owner of those organs, whose autonomy we are trying to respect, wanted them to be used. In that case, one makes a judgment about whether the family is significantly
 distressed. That could clearly be brought out in a code of practice. There are issues to do with the hierarchy; we have the same problem now about how we deal with disagreements.
 If we are to respect the patient's autonomy, the key factor in such an approach, as has been shown in Belgium, is that it is fairer to grieving relatives to ask them about their understanding of their loved one's views, but not to ask them to guess those views or to ask them specifically for their own view. Many patients' relatives do not want to deal with that question, and those who would be distressed by the thought of organ donation have and must be given the opportunity to volunteer that they would be distressed.

Ian Lucas: I am grateful for the hon. Gentleman's continuing patience in giving way. I cannot grasp why it is in order for there to be a general presumption that the deceased person would have given consent, but that the family of that person is not allowed to make an assessment of what the deceased person would have liked. Is that not peculiar?

Evan Harris: I thought that I had made that clear. Exactly what the hon. Gentleman wants would apply. The relatives would be asked whether there was an opt-out—whether the person did not want their organs to be used. The hon. Gentleman is making the point that they are not given an opportunity to guess on the basis of the values of the person concerned, and I accept that that could be an issue. However, if they feel strongly that the person would not have wanted their organs to be used—let us remember that the opt-out would come up all the time, on every trip to the post office and on almost every official form—they would have the opportunity to say that they were distressed because, even though the matter had never been discussed and the person had never taken advantage of the opt-out, they do not think that the person would have wanted to be a donor. That is what happens abroad. There have been a few cases—for example in Belgium—of such reasons being posited, and organs have not been taken. We would be maximising respect for the patient's wishes, but giving scope to meet the stress of relatives as fully as now.
 A further point is that there is now good research to show that many relatives, who at the height of their grief say no to donation because they cannot deal with the decision—they are asked for their decision and not the wishes of their loved one—come to regret not having given their consent at that acute moment, particularly when they hear stories later on about people whose lives have been saved through donation. Some follow-up has taken place, although it is difficult to do, and those are the findings. Such an opt-out system with presumed consent is of benefit to the relatives in not only the acute stage but down the line. 
 For those reasons, we have an a priori obligation to consider changing the system, particularly given the terrifying number of people on the waiting list for transplants. The number has risen inexorably from 5,410 in 1993 to 6,507 in 1998, and from 7,072 in 2002 to 7,278 in 2003. That increase occurs almost every year. There is a similar steady rise in the number of people dying while waiting. Despite the great efforts 
 that have been made, under the current system the number of cadaveric organ donors continues to drop, from 853 in 1993 to 757 in 1998, picking up over four years to 766 in 2002, but dropping in the past full calendar year—2003—to 710. Although one can pick out the financial year of 2002–03 in which there may have been an increase in cadaveric donors, the figures for 2003 are very disappointing. 
 People are dying while waiting, organs are being lost and the majority view of people who want to donate, which is up from 70 to 90 per cent. is not being considered, because 50 per cent. of relatives who are asked for their opinion say no. Therefore, we urgently need to consider the change, and there is good evidence of public support for it. 
 Support exists in not only listeners' polls; a survey of 2,000 people carried out by the National Kidney Research Fund in July 2000 showed that 57 per cent. of those questioned would support a system of presumed consent. A telephone poll conducted by ''Watchdog Healthcheck'' in February 2001 attracted some 52,000 people and found that 78 per cent. of respondents supported a shift to presumed consent. Again, they are responsive polls not scientific samples, so we clearly need more information on the matter. The Department of Health's response that there has not been demonstrable public support and no public debate, when it has not initiated a debate or a fair survey of public opinion, makes it difficult to conclude that the question has been settled.

Ian Gibson: Could the hon. Gentleman enlighten me? What drives and precipitates the increasing demand in the medical community? Has it become more fashionable to have transplantation departments or has some kind of new immunological understanding of the processes increased the possibility of carrying out more transplants? Why is it more likely to see transplantation used? Could he explain the figures that he has quoted and the drive behind the increase? Is there some reason why the science and the medicine have made it more possible?

Evan Harris: The reasons that the hon. Gentleman gives have contributed to an increased demand for transplantation. I am not suggesting that changes to the system would close the gap between the number of donors and people waiting for transplants, but it would contribute about 30 per cent. to its closure—based on studies of its impact in other European countries. We must continue with live donations, non-heart-beating donations, which we will discuss later, and the adequate supply of intensive care facilities.
 There are fewer and fewer road traffic accidents, fortunately, and the morbidity and mortality associated with strokes is decreasing, so donations may come from a diminishing number of people. However, the fact that the total possible number of cadaveric donors is decreasing does not mean that we should not make every effort—as long as it is ethical, acceptable, fair to relatives and maximises the autonomy of donors—to increase the number of organs available. 
 The question of public support is, I accept, key. If a fair opinion poll suggested that people did not support the system, then I do not think that it would be viable. I accept that, because the system is something that can be implemented only with public support. However, I do not think that the question asked in May 1999 comparing the status quo and a system of presumed consent was fair, simply because of the way that it was asked and the fact that 50 per cent. supported the status quo. We need to have an informed debate. 
 Opinion polling since then, including in Scotland, shows that when the two systems are put side by side—rather than presented as involving a shift from the status quo—people do not like the donor card. I do and I am a strong advocate of presumed consent. Only when that is done can we obtain a fair gauge of public support. I am not considering the listeners' poll on Radio 4, or votes on ten-minute Bills by Members, although they are interesting and in support. We need to obtain better judgment of public support, and I hope that by a later stage of the Bill we will be able to do so.

Ian Gibson: I want some information about transplantation. Does the hon. Gentleman have a breakdown of the figures comparing the private and public sectors? Not everybody is like George Best, who can get a transplant in the private sector. I wonder whether there is an increase in private sector transplantation, as against the public sector. Where is the demand and increase being met?

Evan Harris: I understand that the organ donation system, in which one finds an organ available for transplant and looks for a potential recipient, does not distinguish between the private sector and the NHS. Everyone is in the same pool. So I am not sure that I can answer that question.

Ian Gibson: Is there data on it?

Evan Harris: I am not sure that I can answer that question either, and I look to others to do so.
 In summary, I know that this is effectively a First Reading debate of the new clause and that the Minister has made it clear that she does not support it, but I thought that the Committee would benefit from the opportunity to air its view. I am sorry to have taken 18 minutes—with interventions—in so doing.

Andrew Murrison: The hon. Gentleman mentioned seven minutes at the beginning of his speech and I think that he took 24, but we enjoyed it. It was time well spent.
 The issue is a matter of conscience on which individual Members may wish to take a view. I would certainly not wish to represent a corporate view in my remarks. I will put my thoughts on the record and hope that, at least on the Opposition Benches, my comments might be reflected. 
 On the one hand, the hon. Gentleman's remarks raised practical considerations. I share the concern that we need to harvest more organs for transplantation, although we might part company on how that could best be done. On the other hand, there 
 was a philosophical strand to what he said. There he and I part company dramatically. It boils down to what we do with the body parts of other people. If I understand his logic correctly, he assumes that it is okay to use the organs of people who have died, unless they have said that they would rather that the state did not use those organs in that way. That seems to be quite a big move to take philosophically. Certainly it does not subscribe to the way that I like to think about how we do things in this country. I am fascinated to hear about the approach taken on the continent. We have heard about Belgium. I look forward to hearing about the other countries that use that system, and also about those that do not and the reason that they have decided not to do so. 
 We discussed a variety of ways in which we might increase the harvest of organs for transplantation. That would build on the evident success of UK Transplant. It is reasonable to point out, in a non-partisan way of course, that in 1993 the right hon. Member for South-West Surrey (Virginia Bottomley), who is a member of the Committee although sadly not here this afternoon, instituted the organ register, and it has gone from strength to strength. In 1995, 2.25 million people registered with that organisation. That number rose to 5 million by the turn of the century and now rests at something over 11 million, which is extraordinary. When I looked at UK Transplant's website, I was staggered by that—so much so that I hesitated to use those figures earlier because I thought that they might be incorrect. I now understand that they are spot on. That is a lot of people, so we can assume that UK Transplant will go from strength to strength. 
 I said earlier that I was concerned that hospitals were not utilising the huge pool of potential donors correctly, which remains my view. From my experience in practice over a number of years, it seems that for perfectly understandable reasons there were a number of missed opportunities in hospital practice. By and large, practitioners are focused on the individual whom they are treating and might not have a wider view of how they can add to the sum total of human happiness by using organs from that person when, sadly, their efforts on that person's behalf are unsuccessful. There are lots of ways we can achieve the aim that the hon. Member for Oxford, West and Abingdon and I want to work towards—increasing the number of organs available for donation—without going down the route he described. 
 I was reassured slightly by the hon. Gentleman's remarks because it seemed that the presumed consent is not only soft, but even softer than that the British Medical Association is advocating. Perhaps we are moving semantically to the same kind of position. I am still concerned, however, about the presumption that it is all right for the state to take the organs of a citizen without that citizen having explicitly said that that is what they want to happen after their death.

Evan Harris: The hon. Gentleman accepts that that is what happens now. Let us be clear: we are not substituting the presumed consent in the most part for the explicit consent of the person pre-death. We are substituting presumed consent of the donor, who has
 had the opportunity to opt out, for the consent of relatives—the second-guessing of relatives in most cases. In the vast majority of those cases we are taking organs without the explicit consent of the donor.

Andrew Murrison: I think that I follow that. We dealt with the sensitivities and practicalities in dealing with the consent of relatives this morning. The Minister and I came to the conclusion that it would throw up more problems than it would solve to set aside some of the sensibilities of relatives in the process.

Evan Harris: The hon. Gentleman said earlier that it is a leap to move from the current situation, as he put it, of taking organs only with the explicit consent of the persons whose organs they are. I am saying that we should not do that at the moment, except in a small minority of cases where there is a donor card or register. We rely on either the guess of the person's wishes by the relatives, or their own consent, but at the moment in the vast majority of cases we do not rely explicitly on the consent of the owner of those organs.

Andrew Murrison: With transplantation, we are talking about an organ donor card, registration on the register set up for that purpose or the consent of relatives. I agree with the hon. Gentleman's earlier remarks, and we have almost entered the realm of semantics. We are proposing to put into statute a presumed consent—the possibility that the state can take the organs from an individual without them having stated that they wished for that to happen, or indeed their relatives saying that on their behalf. We agree about that.
 I would like to move on and say why the system might be unfair. It would work in favour of those who were aware of the opt-out, such as those who have driving licences in the way that the hon. Gentleman described, who read material that comes through their door, and who are engaged in what is going on. The group it would disadvantage, of course, are those who are one step removed from that—those who are not articulate or indigenous, or those who are less well-off. I am not sure whether the hon. Gentleman had considered that, but I suggest to him that it would certainly be easier in practice for those who are articulate or well educated to opt out, and less easy for those who do not have those qualities or attributes. [Interruption.] Does the hon. Member for Norwich, North (Dr. Gibson) wish to intervene to put his remarks on record? I would be very happy for him to do so, but I see that he does not. 
 The hon. Member for Oxford, West and Abingdon needs to consider that his proposals contain a degree of tacit coercion, although I welcome the way that he has described them because that waters down my original understanding of his intentions. If there were not an element of coercion, there would be little point in his making the proposals in the first place. Presumption means that there is a degree, however subtle, of coercion. 
 The hon. Gentleman is trying to build into the way that we look at transplantation the assumption that one will donate one's organs when one dies. I am not sure about that. He has quoted many figures from opinion polls and the like, flawed and otherwise—some of them quite badly flawed, I suspect—to suggest 
 that the public will go along with that, but I am not convinced that rigorous studies would reveal that people would be entirely comfortable with the idea. We tread on difficult ground if we try to lead opinion rather than mirror what people feel and want. I am, therefore, concerned at the coercive nature of his proposals, although after he has described them so well and at such length, I accept that the coercion is rather less than I had originally anticipated. 
 Personally, I reject his amendments. It is a matter of conscience, and I am sure that, if the matter came to a vote on the Floor of the House, hon. Members on both sides of the House would take contrary views. My personal views are now on record—I suspect that I am not alone in holding them. I am sorry that the hon. Gentleman has moved the amendments, which, in my view, are distinctly illiberal.

Doug Naysmith: I promise that I shall speak for no more than a minute, unlike some other people.
 I want to put my position on record. As I said on Second Reading, I have been in favour of some system of presumed consent—certainly soft presumed consent—for quite a long time. It would be very helpful in the kind of situation that the hon. Member for Oxford, West and Abingdon has described. I agree with many of the things he has said. However, in this Bill we are considering trying to reverse something that happened at Alder Hey and in Bristol. In those cases, criticisms were made of the medical profession over the way in which organs were taken, and the purposes for which they were taken led to criticisms of medical and scientific research. 
 I believe that this Bill will move towards restoring some of the faith in the medical profession and medical scientists that was lost following those happenings. This Bill is not the vehicle for presumed consent. I agree that we need much more discussion on the matter, and I am grateful to the hon. Gentleman for the way in which he has clearly explained the different kinds of presumed consent, but if the amendment were pushed to a vote, I would not support it.

Rosie Winterton: The debate has highlighted some of the major principles around any decision that would be taken to introduce presumed consent in this country. We must consider public opinion. The hon. Member for Oxford, West and Abingdon referred to the paper by Ian Kennedy, who said:
''Clearly, from a moral standpoint, the social context in which any law is to operate and any medical action that arises from it must be a significant consideration in determining policy. Before any such law''—
 that is presumed consent law— 
''is promulgated, there will have to be an informed public debate and a clear demonstration that it would be morally acceptable to most people.''

Evan Harris: I wonder whether the Minister is able to complete the quotation, because I believe it goes on to say:
''Much of the objection to change would be mitigated by appropriate public education.
We feel that this debate should now take place and, unless there is a majority view against change, the contracting out system of organ donation''—
 that is the opting-out system— 
''should be introduced.''
 Ian Kennedy wrote that back in 1998 and he is still waiting for the Department of Health to follow his urgings and start that public debate. Perhaps the Minister is willing to do so now, even at this late stage.

Rosie Winterton: I shall certainly address that point, particularly in relation to the Bill, but in a minute.
 In an article on Belgium's experience of presumed consent, Paul Michielson wrote: 
''No transplantation law can operate efficiently without acceptance by the public.''
 That is exactly my point with regard to the Bill. Following events at Alder Hey and Bristol, and the Isaacs inquiry, we consulted widely for ''Human Bodies, Human Choices''. The majority of the public were happy to donate organs and tissues for a wide variety of purposes, but they wished to be consulted. They wanted to be sure that they knew exactly what would be taken and what it would be used for. The fundamental premise of the Bill is that consent must be obtained to use human organs and tissue, whether from the living or after death. We had an extensive consultation process after the 1998 article with patients, doctors and research groups, and found little support for presumed consent. Therefore, the premise of the Bill is that informed consent should govern our actions. 
 As my hon. Friend the Member for Bristol, North-West (Mr. Naysmith) said, different arguments can be made about presumed consent but, following the tragic experience of thousands of families, we are considering how to deal with informed, as opposed to presumed, consent. The hon. Gentleman seems to be saying that there should be informed consent for the use of organs for medical or research purposes, but presumed consent in the case of transplantation of a deceased person's organs. That would mean two completely different approaches in one Bill.

Evan Harris: The Minister's analysis is correct. I am suggesting that there should be two different processes for different purposes—research and transplantation. I do so because they are different. One has a direct benefit for people whose lives are in danger. It is commonly the practice in Europe to use a system of presumed consent for transplantation and a different system for other purposes. The current system involves relatives' consent in the majority of cases, rather than informed consent of the person concerned.

Rosie Winterton: I shall come on to some of the practical difficulties with the system that the hon. Gentleman proposes. First, I want to deal with the figures that he used this morning, about which I promised to write to Committee members. I hope he will agree, however, that it is more effective to address them now and put my response on the record.
 We discussed the 1 per cent. refusal rate, which came from a MORI poll commissioned by the United Kingdom Transplant Coordinators Association and the British Association of Critical Care Nurses in 1994. The survey has not been repeated, but the UKTCA confirms that family refusals when the wishes of the deceased are known remain rare. Neither recent anecdotal evidence nor any recent data suggests otherwise. 
 The report about the 11 people on the organ donor register who did not become donors comes from an analysis of calls to the duty office of UK Transplant. The analysis was performed from October to December 2003. Some 226 calls were made by health care professionals to check whether a person was on the organ donor register. During the same quarter, all actual organ and tissue donors were checked against the register so that their entry could be removed. 
 Of the 226 calls, 38 were found to be on the register. Of those 38, 10 became solid organ donors, 16 became tissue donors and 11 were non-donors. The reasons for non-donation are not known, but they could include medical contra-indications—they are not necessarily family refusals—which brings us to back to the 1 per cent. rate of family refusal. Of the other 188 inquiries about people who were not on the register, 37 became solid organ donors, 26 tissue-only donors and 128 did not donate. 
 Results from the first three months—April to June 2003—of the potential organ donor audit show that of 495 potential organ donors, 277 were confirmed as suitable. Of those 277, donation was not discussed with 33 families, a figure that we want to improve, and 119 refused, so 125 became solid organ donors. The results show the necessity to ensure that families are approached only by a properly trained health care professional. As witnessed in Spain, that approach could cut refusals to as low as 20 per cent., which is why it is a key plank of our investment in UK Transplant and the transplant framework. 
 The hon. Gentleman also asked about the fluctuation in organ donation rates. Rates were up 6 per cent. in 2002–03. UK Transplant reported that, for the first quarter of 2003–04, cadaveric donation rates were down by 10 per cent. However, quarterly rates regularly fluctuate between fewer than 165 donors and more than 230 donors. The figure for the lowest quarter since 2001 is 163 and the figure for the highest is 236. That is well in excess of that 10 per cent. variation. It is difficult to use any individual quarter to project the annual rate. 
 The hon. Gentleman has obviously made valid points about the need to increase organ donation and he proposed an alternative system, which he suggests would be more effective in increasing the organ donation rate. However, I refer him to the point that I made earlier. Spain does have the highest rate of organ donation in the world, but although it has a presumed consent law, it is not operated in practice. The Spanish transplant organisation takes a positive pride in the fact that the consent of those closest to the donor is always sought. 
 Dr. Rafael Matesanz, who has made no secret of his views, publicly stated a number of times, including at a symposium at the Royal College of Physicians in 2001 organised by the National Kidney Research Fund, that the legal basis of consent for donation is not the relevant factor in increasing donation rates. In his presentation, he said: 
''In 1989, when the National Transplants Organisation was created, there were many people in Spain who believed that the main solution to solving the organ shortage was to change the legislation and apply strict presumed consent laws. However, we found little evidence to suggest that the style of legislation influences the organ donor, because regardless of how the donor might become available, relatives are always consulted, as in most European countries, and their wishes are always respected. In Spain, despite the very large increase in organ donation, over 20 per cent. of families refuse to allow organ donation to take place. This has fallen from 30 per cent. in the early 1990s but is still high.''
 So there is the practical point that nowadays it is absolutely necessary to carry out the screening process to which I referred, which gives people the opportunity not to co-operate if they do not wish to do so. There is also the fact that, even where presumed consent operates—in France the system changed because it was felt to be unacceptable—consent is always sought. 
 Personally, I found the arguments used by the hon. Member for Spelthorne (Mr. Wilshire) on Second Reading very persuasive. I am aware that the proposal does not include children, but similar pressures would apply. Hon. Members will recall that he said that he had not been approached and always regretted that because he would have consented in the circumstances. However, he also said, ''I feel that if it had been presumed that I would give my consent, I would have felt guilty in not doing so, even if I had not wanted to.'' 
 That pressure also applies to relatives, whether the deceased was a child or another close relative. That is what I shall bear in mind when I consider the presumed consent that the hon. Member for Oxford, West and Abingdon is proposing. Our evidence shows that it is extremely persuasive if relatives are told that it was the positive wish of the deceased to donate his or her organs. If there has not been a positive decision to opt out—this goes back to the point made by the hon. Member for Westbury—I suggest that it would be up to the relatives to decide, because, under the system proposed by the hon. Member for Oxford, West and Abingdon, there would still be a requirement to return to the relatives, who would have to make a judgment. If they do not have the positive indication that our system would provide, I suggest that it would be more difficult for them make up their mind. Under our system, there would be a positive indication in favour of donation as opposed to a positive indication against it. I suggest that that is far more persuasive for a relative. We must persuade people to make a positive opting-in proposal because all the evidence shows that only 1 per cent. of people would go against those wishes.

Evan Harris: At the moment, there has been no opt-in in 80 per cent. of cases and relatives are asked to decide. We know that about 20 per cent. of people carry donor cards. If someone has not chosen to carry
 a donor card to mention their intentions, or to opt in on the register, relatives might be more likely to assume that the deceased's wish was not to donate because they had not opted in. That is contrary to the general position shown by people's wishes. I think that the argument works the other way from that suggested by the Minister.

Rosie Winterton: That is arguable. There are two scenarios. From the figures that we have, it seems that about one third of people said that organ donation could go ahead, although there was no indication of what their relative wanted. Over and above that, we know that when there has been a positive indication, only 1 per cent. of relatives refuse. A more positive approach is to increase the number of people on the organ donor register, and we must consider ways of doing so—for example, with an electronic patient record. The hon. Member for Oxford, West and Abingdon referred to driving licences and that system is having an increased effect, having reached more than 6 million people. The single most important measure is that people in intensive care units are able to approach relatives in the correct way.
 We already have 35 donor liaison nurses in place. We want every hospital intensive care unit to have a properly trained person who can approach relatives and make the appropriate inquiries. If they are armed with that positive opt-in to the system, there is likely to be a refusal in only 1 per cent. of cases. I know that the hon. Gentleman is keen to increase the amount of organ donation carried out, but I emphasise to him that all the evidence shows that increasing the number of people on the organ donor register is likely to be the most effective way of increasing organ donation. That also fits in with the principles of the Bill. Given the discussion that has taken place about the background to the Bill—the debate that took place about presumed consent when we conducted our consultation—we feel that that is the way forward, and we will continue to do everything that we can to encourage that.

Andrew Murrison: I am grateful to the Minister and am sure that she consulted the Royal College of Nursing as part of her consultation exercise. It is important to put on record the strong feeling of the RCN against presumed consent. The findings of its conference suggested that more resources might be dedicated towards nurses, who tend to be at the front line in discussion of sensitive issues with the bereaved. Would she agree that that is likely to increase the harvest of organs and that the RCN is right to oppose presumed consent?

Rosie Winterton: I am grateful to the hon. Gentleman for reminding the Committee of the views of the RCN. The same view is held by UK Transplant, which feels strongly that individuals should have the opportunity to decide whether to donate after death. The fear of UK Transplant was that an opt-out system would mean that people would fail to register an objection, there would be undue distress to families and that what might happen is, to an extent, the experience of France where the system fell into disrepute.
 We do not want to take that approach. We want to take a positive opt-in approach. We will continue to take measures to make that as easy as possible. I say to 
 the hon. Member for Oxford, West and Abingdon that, particularly in the light of this legislation and the discussions and consultation that went with it, we feel that that is the best way forward. I am afraid that his amendment would go against some of the fundamental principles set out in the Bill. Therefore, I urge him to withdraw the amendment.

Evan Harris: I am grateful to the Minister and other hon. Members that we have been able to have a debate on the issue and for the manner in which the debate was held.
 I, along with many others who support the measure, would not be proposing a change if the system were working and if we had 80 per cent. of people on the organ donor register, and therefore less than 48 per cent. of relatives were not disagreeing to organ donation. We are not in that position. 
 Although I hope that I am wrong, the trends are not encouraging. We now have the figures for the first three quarters of the year 2003–04. In the calendar year 2003, there were 710 cadaveric donors. That takes the figures from the last quarter of 2002–03 and from the first three quarters of 2003–04. The number for the calendar year 2002 was 766 such donors. That is a drop of 7.3 per cent. calendar year to calendar year at a time when the number of people registering on the organ donor register has been increasing thanks to the work of the Minister, her officials and UK Transplant. The signs are not good. I hope that I am wrong and that there will be a sudden turnaround, but it does not look good. 
 If the hon. Lady is arguing that the problem is that people approaching relatives are not yet sufficiently trained, and that she has a programme of training, she must explain why the rejection rate by relatives of donors, which was only 30 per cent. in 1993, according to the Sheila Gore study, has increased to 48 per cent. That was the previous study, and was the only one that we could examine before we had the donor audit. People have not become less trained in the past 10 years; if anything, they have become more experienced. There has been a particular drive in that area thanks to the resources allocated in recent years by the Government, so I ask the Minister to reflect on whether she can rely on that defence. 
 The evidence from abroad clearly shows that presumed consent would work. Gimble et al conclude: 
''Evidence from this study, and from the studies previously discussed''—
 those are the other reviews— 
''clearly suggest that the practice of presumed consent (opting-out) legislation has had a significant effect on the number of cadaveric donors per million population. As the gap between the supply and demand for transplant organs continues to widen, professionals and policymakers should consider revisiting the implications of this legislation, or some hybrid of alternatives, as an effort to expand the 'gift of life' to those in need.''
 There is a pressing urgency. The evidence, rather than the anecdotes and the opinion of Mr. Matesanz, who I am sure is well respected in Spain, suggests that it would work. 
 Before we revisit the matter, we must consider the figures on public acceptability that the Minister has provided. In seeking the leave of the Committee to withdraw the amendments, I thank her for setting out some of the hurdles that those of us who support the measure will have to cross. I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn. 
 The Chairman, being of the opinion that the principle of the clause and any matters arising thereon had been adequately discussed in the course of the debate on the amendments proposed thereto, forthwith put the Question, pursuant to Standing Orders Nos. 68 and 69, That the clause stand part of the Bill. 
 Question agreed to. 
 Clause 3 ordered to stand part of the Bill.

Clause 4 - Nominated representatives

Andrew Lansley: I beg to move amendment No. 10, in
clause 4, page 5, line 10, at end insert— 
 '(8A) If, in accordance with the requirements of subsections (3) to (5), a person writes to disallow any person from enjoying a qualifying relationship as defined in section 24, then that adverse nomination shall apply in relation to appropriate consent.'.
 A provision in clause 4 allows a person, having been nominated, to renounce their appointment. I point that out because amendment No. 10 is designed to explore the question not so much of a nominated representative, but of a person who is in a ''qualifying relationship''. 
 If an individual has not provided consent and has not nominated anyone as their representative, after their death the provisions in clause 24 would come into effect. However, clause 24 does not permit anyone, by virtue of an instrument of the sort set out in clause 4(3) to (5), to vary in advance who is in a ''qualifying relationship'' with them for the purposes of giving consent. 
 If I am wrong, I will be pleased to hear why; otherwise, I hope that it might be possible to include the amendment. It is always a sensitive issue, but none of us is without experience of families in which, if they thought about it, some people would be excluded from the ''qualifying relationship'' of others. We should permit it.

Stephen Ladyman: I guess that we could call it the amendment to ensure that the annoying relative who gets drunk at family Christmas parties is in no position to dispose of one's body parts after death. Although I have no experience of the hon. Gentleman's family, I can see why in principle he would consider the amendment necessary.
 Sufficient safeguards already exist in the Bill, however. Were someone to go to the trouble of identifying another whom they did not want to be nominated to act on their behalf, it would be more simple to do it the other way round by nominating someone to act on their behalf. That is already in the Bill, so we have already adequately covered the amendment. I undertake to consider it further before 
 Report, but it is an unnecessary amendment and I hope that the hon. Gentleman will withdraw it.

Andrew Lansley: I am grateful to the Under-Secretary, not least for agreeing to think about this matter. It seems rather a burdensome and unlikely proposition that people will specify their own structure of qualifying relationships prior to death, and more likely that they might specify who was not in a qualifying relationship with them. It is rather like constructing a will—the difficulty being that one does this on the basis of a range of hypothetical circumstances that might accrue before the point of one's death. In practice, it is probably simpler to exclude somebody from a qualifying relationship than to anticipate all the circumstances that might arise before death. If the Under-Secretary is willing to think about it, I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Clause 4 ordered to stand part of the Bill.

Clause 5 - Prohibition of activities without consent etc.

Andrew Murrison: I beg to move amendment No. 22, in
clause 5, page 5, line 18, after 'does', insert 
 'or causes to be done'.
 The purpose behind the amendment is fairly clear to anybody who has read the various briefing notes with which medical research organisations—particularly pathologists—have regaled us. They are concerned about the apparently unfair onus that will be placed upon them—given that they are most unlikely to be actively involved in obtaining consent—rather than on clinicians, who would be actively involved. Therefore, there is some fear among the organisations that represent pathologists and medical researchers that they will be unduly affected by the Bill. The focus is very much on them, and not on clinicians, who are really in the front line of the gaining of consent. 
 Much of the concern has to do with the slightly ambiguous language in the Bill. The Under-Secretary has explained that much of it will be fleshed out in codes of practice, but as we have discussed before, that will not give a great deal of comfort to those organisations that represent pathologists and medical researchers. Indeed, in clause 5(1) we have the words ''reasonably believes''. The word reasonably is something that we could argue about, and no doubt lawyers will argue about it at great length and cost in the law courts. It is that sort of ambiguity that worries many of the organisations to which I have referred, and those concerns are well founded. 
 It is important for organisations such as the BioIndustry Association and others that have corresponded with us that the focus is shifted slightly away from them, and on to those who are involved with the garnering of informed consent—in practice, that tends to mean clinicians. All that the insertion of ''causes to be done'' will do is shift that burden slightly closer to the clinician who is involved with the patient. I think that that is a reasonable small addition to the 
 Bill, and will address some of the concerns of the likes of the BioIndustry Association and those organisations representing workers in medical research and in pathology. I hope that the Under-Secretary will consider accepting that amendment and keeping those organisations happy.

Stephen Ladyman: Again, I understand what the hon. Gentleman is getting at, and it bears repeating that we greatly respect the work that pathologists and others do, and we recognise the difficulties that they face and the worries that they have in this regard. I hope that I am able to clarify that our belief that the existing wording of the Bill is an adequate protection for them. It makes it clear that a reasonable belief that consent had been obtained would be a perfectly good defence were anyone to face sanctions under the legislation. If they were being asked to do something when they knew that consent had not been obtained, the criminal liability in the Human Organ Transplants Act 1989 would be a perfectly legitimate reason for them to refuse to do it. Both of those purposes are covered.
 We also believe that were someone required by another person to do something that went against the provisions of the 1989 Act, the Bill would cover it. That person would in effect be committing a criminal activity. For example, if a supervisor in a laboratory required his PhD students to carry out work knowing that consent had not been properly obtained, the supervisor would face the criminal sanction. We believe that the wording in the Act is sufficient to guarantee protection for people in such circumstances.

Andrew Murrison: I think the Under-Secretary has answered my principal concern, but just for clarification I would like to exemplify my concerns. A clinician on a ward has a patient, on whom he wants a pathologist to undertake an examination. The clinician says to the pathologist, ''Consent has been gained.'' The pathologist takes that in good faith, and his defence would be that he reasonably believed that consent had been gained. Where would the blame lie if that consent had not been obtained, and who would be in the frame?

Stephen Ladyman: The pathologist would have a good defence by claiming that he had reasonable belief that consent had been obtained. It is my view that in those circumstances the clinician—especially if he were aware that consent had not been obtained when he gave that guidance—would be liable. I shall certainly undertake to reflect further on that point before Report, but those points are covered by the wording in the 1989 Act, and the Bill will sufficiently cover the hon. Gentleman's points. On that basis, I hope that he is prepared to withdraw the amendment.

Andrew Murrison: Given the Under-Secretary's assurances and the fact that he will think about the matter, I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn.

Andrew Lansley: I beg to move amendment No. 138, in
clause 5, page 6, line 7, leave out '12' and insert '3'.

Alan Hurst: With this it will be convenient to discuss the following:
 Amendment No. 139, in 
clause 5, page 6, line 8, leave out 'the statutory maximum' and insert 
 'level 5 on the standard scale'.
 Amendment No. 140, in 
clause 5, page 6, line 11, leave out '3 years' and insert '12 months'.

Andrew Lansley: We turn to the question of associated penalties. I am sure that Committee members will be aware of the concerns that have been raised about the introduction of penalties and the views expressed in certain places that they seem harsh. I was aware that the consultation contemplated the introduction of penalties, and although there were divergent views as to the appropriate severity of those penalties, there was broadly a consensus that enforcement and penalties were required.
 When I read the Bill, I was slightly surprised at the severity of penalties because I had anticipated that they would be in line with the existing penalties under the Human Organ Transplants Act 1989. I do not necessarily seek to substitute my view for the Government's, but the amendment is in line with the 1989 Act. The penalties in the clause are substantially in excess of that, and at the time of consultation the Government's consultation document stated that they were not aware of any concerns about the suitability of the provisions relating to penalties. 
 I was surprised at the general application of the penalties to a range of offences, many of which are similar to those that related to commercial dealings in human material in the past. We are talking about an offence of similar severity, so why has there been a shift? 
 From the point of view of those who are affected by the legislation, and to whom such penalties might be applied, imprisonment seems to me a sufficiently severe penalty in itself. A fine at level 5 might be exactly the same as the standard statutory maximum—it is certainly not far off it. The provision for 12 months' imprisonment on summary conviction, or three years on indictment, seems excessive. I would be interested to hear the reasoning behind the Government's decision to increase the penalties.

Stephen Ladyman: As always, these things are judgment calls. The hon. Gentleman has clearly spoken to some people who think that the penalties are too severe; I assure him that we have spoken to people who do not think that they are severe enough. We have come to a judgment. We can debate its merits, but it is our judgment.
 We hope that the penalties in the clause will never have to be imposed, or will be imposed only rarely. We hope that the legislation is clear enough and that the willingness of clinicians and researchers to co-operate with it will be such that it will never be necessary to bring any cases to trial. If a case does come to trial, we think that we have the judgment right. We consulted the Home Office on the appropriate level of penalties for the offences. There is provision for penalties to vary depending on the seriousness of the offence and whether it is dealt with on summary conviction or on indictment. No person may be prosecuted for an offence under the clause without the consent of the 
 Director of Public Prosecutions. Subsections (1) and (4) also make it clear that it will be a defence if a person ''reasonably believes'' that he has consent, or that the activity that he is undertaking does not require consent. 
 I made those points when we debated the previous amendment. May I correct something that I said in that debate? In the example that the hon. Member for Westbury gave, I think I said that the clinician would be liable under the Bill. It is my understanding, in fact, that neither the clinician nor the pathologist would be liable in those circumstances. The clinician is not carrying out a licensable activity, and so the penalties would not be imposed on him or her. I hope that I have clarified that.

Andrew Murrison: Oh!

Stephen Ladyman: I can tell from the hon. Gentleman's furrowed brow and his exclamation that the Opposition are probably already writing amendments for consideration on Report.

Andrew Murrison: That is quite something. My word! I asked who would be in the frame, because when something goes wrong, people naturally want a culprit—

Andrew Lansley: Ours is rather a good amendment.

Andrew Murrison: Indeed. I wonder whether, in the light of the information from the Under-Secretary's civil servants, he will retrospectively consider the amendment that I withdrew.

Stephen Ladyman: I understand the hon. Gentleman's concerns. We probably all need to think about the clause before Report. My understanding is that if somebody were deliberately flouting the proposed legislation, there would be penalties that could be used. However, we certainly need to reflect on these matters. The hon. Gentleman is right to say that in such circumstances somebody should be held responsible. We must ensure that that is covered in the Bill. I believe that it is, but if it turns out not be, he can rest assured that we will address that.
 Amendment No. 139 would change the wording of the clause so that instead of referring to the ''statutory maximum'' it referred to 
''level 5 on the standard scale''.
 That would have no effect, because both amounts would be £5,000. Since the offence is triable either way, the correct term to use when the offence is tried summarily is the ''statutory maximum''. It is only for summary offences that the standard scale is used. I hope that, with that explanation, the hon. Gentleman will withdraw his amendment.

Andrew Lansley: I half suspected that that was true in relation to amendment No. 139, but it does not change the point in relation to amendment No. 138. As I understand it, the Human Organ Transplants Act 1989 includes a penalty not for conviction on indictment but only on summary conviction, and that was for three months. As the Under-Secretary said, it is a matter of judgment. My judgment is that 12 months is excessive and that, in particular, no justification has been
 presented to move from what was a penalty in relation to commercial dealings in human organs. That seems to me to be a serious offence, and there is no evidence that that penalty has been seen to be insufficient in relation to that offence in the past to warrant this shift to a more severe penalty now.

Stephen Ladyman: To return to the phrase that I used during discussion of earlier amendments, the golden thread that runs through the Bill is that people must have consented to the use of their own bodies. It is sacrosanct that we control our own bodies. We are discussing an offence where someone wilfully ignores the wishes of an individual, either by not seeking to ascertain what those wishes are or by ignoring them when they know about them. That is a serious matter and the serious penalties that we are suggesting in the Bill might, in certain circumstances, be entirely appropriate and should be at the disposal of the courts.

Andrew Lansley: We can differ on this, but I cannot change how I propose to proceed. I shall not press the amendment now but that is not because I agree with the Under-Secretary.
 I was trying to ascertain whether there was a clear process by which the Government had arrived at their judgment. It seems to me that it is based on the views that have been expressed to the Department. I am not aware that those views were canvassed specifically in the consultation. I am not persuaded, but we will go away and ask for views between now and Report from those who may be affected and families who, quite rightly, want to see enforcement and penalties that seem to them to be commensurate with the seriousness of the offence. In the light of those views, we shall take a view on the appropriateness of seeking to raise the matter again on Report. I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn. 
 Clause 5 ordered to stand part of the Bill.

Clause 6 - Restriction of activities in relation to

Evan Harris: I beg to move amendment No. 144, in
clause 6, page 6, line 35, leave out 'decent' and insert 'safe and lawful'.

Alan Hurst: With this it will be convenient to discuss the following:
 Amendment No. 147, in 
schedule 3, page 44, line 28, leave out 'decent' and insert 'safe and lawful'.
 Amendment No. 145, in 
clause 28, page 18, line 18, leave out 'decent' and insert 'safe and lawful'.
 Amendment No. 146, in 
clause 56, page 33, line 41, leave out 'decent' and insert 'safe and lawful'.

Evan Harris: I would be grateful if the Under-Secretary could explain how ''decent disposal'' is defined and why that is a better term, defined or otherwise, than ''safe and lawful disposal'', which is
 proposed in the amendment to this clause and the other clauses in which it appears.

Richard Taylor: To give the Under-Secretary a moment more, may I remind him of the words in the code of practice for families and post mortems? I, too, am worried about the word ''decent''. Does that cover the words in the code of practice:
''Tissue and organs should be handled respectfully at all times . . . The method of disposal must be legal''?
 With the hon. Member for Oxford, West and Abingdon, I am a little concerned that the word ''decent'' is not quite strong enough or adequate enough to cover the method of disposal.

Stephen Ladyman: The amendments would change both the wording and the sense of the clauses, which, as the hon. Member for Oxford, West and Abingdon said, refer to the disposal of bodies and body parts. He suggested the alternative wording ''safe and lawful'', but that does not convey the important idea that the disposal of human bodies or material should be accorded respect appropriate to them, which is what we are trying to achieve.
 ''Decent disposal'' in relation to whole bodies is a familiar term from the Anatomy Act 1984. It is not the Government's wish to provide exemptions from the offences in clauses 6 and 28 covering the disposal of bodies in any way other than a decent one. 
 I hope that it would be helpful if I paraphrase the relevant part of the regulations under the 1984 Act. The Anatomy Regulations 1988 state that disposal of a body after anatomical examination shall, so far as is practicable, be in accordance with any wishes expressed by the deceased or any surviving spouse or surviving relative, and separated parts of the body shall, so far as is practicable, be disposed of with the body from which they were removed. 
 We recognise that disposal of parts of bodies, particularly small parts, is different from the disposal of whole bodies. For that reason, clause 56(5) provides that decent disposal, in relation to material that has come from a body, includes disposal as waste. It is not necessarily the size of the material that should determine the manner of its disposal. There may be enormous differences in how even relatively small amounts of tissue should be disposed of, the obvious example being foetal tissue. For that reason, the Government believe that it is appropriate to put in legislation the concept of decent disposal, but also to deal with the vast range and complexity of the situation to which it applies through the guidance. 
 Clause 23(2)(1) provides that the Human Tissue Authority's code of practice must deal with the disposal of relevant material, and that that will provide adequate insurance that disposal will be safe and lawful. I hope that that is the assurance that the hon. Members for Oxford, West and Abingdon and for Wyre Forest are seeking, and that the hon. Member for Oxford, West will withdraw his amendment.

Evan Harris: It does, indeed, appear to be the assurance that we sought. I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Clause 6 ordered to stand part of the Bill.

Clause 7 - Existing holdings

Stephen Ladyman: I beg to move amendment No. 33, in
clause 7, page 7, line 7, at end insert— 
 '( ) Section 5(1) shall have effect as if the activities mentioned in subsection (1) were not activities to which section 1(1) applies.'.
 The amendment corrects a drafting error in clause 7, proving that, very occasionally, even the Government make mistakes. The effect of clause 7, as drafted, is that it would be an offence under clause 5(1) to use existing holdings without appropriate consent. Clause 7(1) provides that clause 1(1) applies to existing holdings without the requirement for appropriate consent. That means that it is lawful to use existing holdings for scheduled purposes without needing to go back and obtain consent. 
 Clause 5, however, makes it an offence to undertake the activities to which clause 1(1) applies without obtaining appropriate consent. Such activities include storing and using relevant material for scheduled purposes. Clearly, the intention of clause 7 would be defeated if clause 5 made it an offence to continue to store and use existing holdings without appropriate consent. So, the amendment corrects that by providing that clause 5(1) is to be read as though the storage and use of existing holdings were not activities to which clause 1(1) applies. I hope that that is clear to all hon. Members and that they will accept the Government's amendment. 
 Amendment agreed to.

Richard Taylor: I beg to move amendment No. 55, in
clause 7, page 7, line 12, at end add 
 'or that has been used for a purpose specified in Schedule 1'.
 I have to declare a personal interest. My local newspaper has written reports saying that many Members have imaginary skeletons in their cupboards. I have a real one, as many doctors of my vintage do. I am concerned that, as the Bill is written, I am not lawfully allowed to have that. I cannot, as the hon. Member for Westbury did some years ago, dispose of mine because that is not covered either. So, the purpose of the words that I seek to add to the Bill is to try to make it legal to have possession of something that was used at one time. However, if the Under-Secretary can reassure me and many other doctors of my sort of age that I am not liable to 51 weeks in prison, or whatever the punishment is, I shall certainly seek leave to withdraw the amendment.

Andrew Murrison: I, too, was once the owner of a skeleton—I confess that I am no longer in possession of it. It is a serious point, because there is a considerable number of medical students, and potentially this loophole could criminalise them, which would be terrible. Things have moved on somewhat since the hon. Member for Wyre Forest qualified—in this day and age, a medical student usually has a half-skeleton. Traditionally, those skeletons are sold on to oncoming medical students by those who have qualified. That seems to me to be
 perfectly legitimate, and I doubt that there is any profit involved. It means that those skeletons are recycled, and I am sure that most of us would say that that is a good thing. The Under-Secretary may wish to reflect on that rather peculiar situation, and perhaps on whether the amendment put forward by the hon. Member for Wyre Forest is a good one to include in the Bill to close this loophole.

Stephen Ladyman: Seldom have I heard Members admitting to such debauched acts. I was going to give the hon. Gentlemen the assurances that they seek, but the thought of banging them away for three years each is intriguing me. Having said that, I can give them and other holders of skeletons the assurance that they want.
 The consent provisions of clause 1 do not apply to use of material held for scheduled purposes at the time the Bill comes into force, or to imported bodies and material, or to bodies and material which have come from a person who died more than 100 years before Bill comes into force. It will be lawful to continue to keep and use human material already retained in archives when the Bill takes effect, where these are held for scheduled purposes. The Human Tissue Authority will have the role of advising on how currently stored tissue and organs should be dealt with. The Authority will issue a statutory code of practice setting standards and giving guidance about existing holdings. This will follow on from the existing guidance issued by the Department in April 2003, ''An Interim Statement on the Use of Human Organs and Tissue''. 
 The intention behind clause 7 is to ensure that it is lawful to continue to store and use existing holdings for scheduled purposes without needing appropriate consent, once the Bill comes into force, subject to guidance. This applies, however, only to material that is still held for scheduled purposes, and not to material that is no longer required, even though it may have been used in the past for scheduled purposes. Such material should be disposed of. 
 The Bill does not prevent existing holdings of material that have already been used for scheduled purposes being used again for the same purpose, or even for other scheduled purposes, subject to the guidance to be issued by the Human Tissue Authority. The Bill is clear, however, that in future, where consent is given to the use of material for a particular scheduled purpose, the tissue may not be subsequently used for a different scheduled purpose without consent for that purpose. Skeletons currently in the possession of medical students and former medical students may continue to be kept and used for purposes listed in schedule 1 as they are existing holdings under clause 7. Future use of existing holdings will be subject to guidance given in the statutory code of practice, as stated in clause 23. Skeletons may be imported from abroad, but will be the subject of the HTA's code of practice on import and export, and will fall within the regulatory scheme in the same way as any other tissue. The code of practice will ensure that appropriate ethical standards have been applied abroad.

Andrew Lansley: May we therefore conclude that in the case of a former medical student who has retained his
 skeleton, but who has no scheduled purpose in mind, it would no longer be lawful to retain that holding, and in particular to hold it at home, or elsewhere not on licensed premises, or, further to that, to sell it?

Stephen Ladyman: My understanding is that private use would be acceptable under the circumstances, but the holder could not sell it. So in the coming years some skeletons may need to be donated to future medical students. They can be passed on but they cannot be sold.

Evan Harris: I am intrigued by the idea of private use. Does that mean, for instance, that if the hon. Member for Wyre Forest sits at home with his skeleton, stroking it in a loving manner—but no more—that is private use? I do not understand what private use is in that respect as distinct from other uses.

Stephen Ladyman: Public display would not be lawful, but private use—presumably the hon. Member for Wyre Forest would be using the skeleton for his personal education, which was why he initially obtained it—would be acceptable. I hope that with those assurances, and as long as Opposition Members do not have any more skeletons in their cupboards, the hon. Gentleman will withdraw the amendment.

Andrew Murrison: I am not entirely clear on this matter, and it is an interesting and important point. Is the Under-Secretary saying that medical students will no longer be able to sell their skeletons to each other?

Stephen Ladyman: That is correct. I have concluded my comments and I hope that the amendment will be withdrawn.

Richard Taylor: The first part of the Under-Secretary's contribution was rather above me, but I understood the last part absolutely. If medical students can currently afford to buy a half skeleton, which, going by the rate of inflation, costs as much as £240, and they are not allowed to—

Stephen Ladyman: I should point out that we will be providing them with much more generous student loans.

Richard Taylor: As I am reassured, I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
Harry Cohen (Leyton and Wanstead) (Lab) rose—

Alan Hurst: Order. The hon. Gentleman is too late.
 Question proposed, That the clause stand part of the Bill.

Harry Cohen: I want to pick up on the point about students being unable to sell a skeleton that they own to another student. The Under-Secretary said that it would not be allowed under the terms of the Bill. I cannot see why, under those restricted circumstances, selling would be unreasonable. The Under-Secretary should consider that and enable a student who has finished using his skeleton to sell it to another student for the same purpose.

Stephen Ladyman: I will consider that. The important point is that the student cannot make a profit. They
 could exchange it for the same price, but I suspect that there will be an increased use of plastic skeletons in future.
 Question put and agreed to. 
 Clause 7, as amended, ordered to stand part of the Bill.

Clause 8 - Existing anatomical specimens

Andrew Murrison: I beg to move amendment No. 24, in
clause 8, page 8, line 14, leave out subsection (9).
 I cannot promise that the amendment will be anything like as entertaining as the previous one; indeed, I can promise that it will be extremely dull. 
 The Under-Secretary will appreciate the concerns of many hon. Members about the powers that the Secretary of State might have under the Bill. The purpose of the amendment is to tease out a description of what is meant by amending subsection (8) and the qualifying purposes therein.

Stephen Ladyman: I am not sure that I can give the hon. Gentleman the entertaining explanation that he is looking for. It would be unfortunate to remove the order-making power because it necessarily reflects the order-making power in clause 1(8).
 The activities that are authorised to be carried out with former anatomical specimens are set out in clause 8(8) by reference to the purposes in schedule 1, in common with the Bill's theme to deal with those purposes. The purposes listed in schedule 1 can be altered by order under clause 1(8). If the proposed power were to be exercised, it could make a nonsense of clause 8(8). We therefore need an order-making power to ensure that any order under clause 1(8) can be accompanied by the necessary consequential amendments to clause 8(8). With that, I hope that the hon. Gentleman will withdraw the amendment.

Andrew Murrison: The Under-Secretary was quite right: that was a very dull explanation. Nevertheless, the hour is late, so I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Clause 8 ordered to stand part of the Bill.

Clause 9 - Coroners

Andrew Lansley: I beg to move amendment No. 13, in
clause 9, page 8, line 17, leave out 'or' and insert 'and'.

Alan Hurst: With this we may discuss Amendment No. 25, in
clause 9, page 8, line 22, leave out 'with the consent' and insert 'under the authority'.

Andrew Lansley: The amendments deal essentially with the same point. The clause relates to the coroner's powers. As we understand the position, we are not legislating to interfere with their existing practices, which is fine. Indeed, subsection (1) states:
''Nothing in this Part applies to anything done for purposes of functions of a coroner or under the authority of a coroner.''
 What is done under the authority of a coroner that is not for the purposes of their functions? Why does the clause say: 
''or under the authority of a coroner'',
 rather than ''and under the authority of a coroner''? An action would then have to be both for the coroner's purposes and with his authority. 
 Amendment No. 25 relates to subsection (2)(b), which specifies that people who deal with material that should be in the hands of the coroner for the purposes of the coroner cannot act on the authority available under clause 1. However, the end of subsection (2) adds the words: 
''except with the consent of the coroner.''
 Like the ''or'' in subsection (1), that suggests that we are dealing with activities that go beyond the purposes of the functions of a coroner, but which coroners may authorise in lieu of consent. I am not at all sure that we intend them to act in that way. As it happens, amendment No. 26 makes the same point on requiring an activity that is no longer for the purposes of the functions of a coroner to be undertaken with appropriate or qualifying consent, depending on whether it is a scheduled purpose or DNA analysis. 
 The question at the heart of the amendments is, therefore, whether the Government permit activities that go beyond the functions of a coroner, on the authority of a coroner who is acting in lieu of consent. That was not our understanding of the purpose of clause 9.

Stephen Ladyman: The intention is certainly that the Bill should not interfere with the powers and duties of coroners. I think that we all understand that. However, coroners have a duty to act in different circumstances, and we would not want a nominated representative to interfere with those duties. I am sure that there would be no dispute between us over the fact that the coroner's powers should be protected if he suspected, for example, that something had to be investigated. However, coroners have other, wider duties under case law. For example, they may wish to order the storage and retention of bodies for the purposes of a defendant who needs the material to mount a defence in a case in which they are accused of having acted improperly. The coroner therefore has a wide range of responsibilities, which we must ensure are protected.
 Amendment No. 13 would constrain a coroner from giving, in the interest of justice, a lawful direction to retain a body or human remains. If a coroner were able only to authorise retention or use in connection with his statutory functions, the nominated representative or person in a qualifying relationship would be able to prevent further examination of the remains on behalf of a person charged with connection of the death. That could result in failure to convict the guilty or acquit the innocent.

Andrew Lansley: I do not understand that. Would that not be covered by the exceptions under clause 40?

Stephen Ladyman: As the Bill stands, the coroner's interest is protected, but we are discussing the impact of the hon. Gentleman's amendment on the Bill. I believe that he can be reassured.

Andrew Lansley: Let me explain to the Under-Secretary. Even if he were right about the impact of our amendment—I do not concede that he is—the example he is using is drawn from the conduct of a prosecution, but the conduct of a prosecution is specifically exempted from the impact of clauses relating to consent by the terms of clause 40(1)(b).

Stephen Ladyman: It has been suggested to me that clause 40 relates only to the licensing regime under part 2 and not consent under part 1, so that is probably the technical answer to the hon. Gentleman's question. However, we are not necessarily talking about the coroner's duties in respect of a prosecution. There may be a wider duty for the coroner to protect evidence in relation to other matters where people have been wrongly accused or may feel that material is necessary to some future action. It is those powers that we need to protect.
 My hon. Friend the Member for Leyton and Wanstead raised the point during the previous session that we have to protect the duty of a coroner to carry out his wider functions and not allow people who may be nominated or in a qualifying relationship to interfere with those duties. That is how the Bill is drafted.

Evan Harris: The Under-Secretary talked about needing to protect the ability of the coroner to carry out his wider functions, but surely that would be covered by the first part of subsection (1), which states:
''purposes of functions of a coroner''.
 Therefore the alternate phrase— 
''or under the authority of a coroner''—
 is not required.

Stephen Ladyman: No. The Bill protects those functions. I do not believe, as the amendment suggests, that the Bill weakens the protection of coroners. It is on that basis that I think the amendments are flawed.
 There may be a limited number of other circumstances in which a coroner should be able to act judicially to retain material for a proper purpose, and it would not be appropriate to seek to qualify how a coroner might exercise his discretion under the common law. That would have, and could have, unintended and unhelpful consequences. It would not enable a coroner to authorise storage or retention of material for purposes that will require consent beyond the period for which he has jurisdiction. I hope that that is one assurance that the hon. Gentleman sought. We are not attempting to give coroners new powers that would override the golden thread of the necessity of consent for other purposes that we have built into the Bill. 
 On amendment No. 25, the aim of the existing provision in subsection (2) is simply to ensure that the coroner has the power to prevent an action that might interfere with his duty to investigate as long as he has jurisdiction of the body. We do not consider that the provision introduces any new requirement for 
 pathologists to seek express consent from the coroner to remove or retain material in connection with the investigation of the death.

Evan Harris: Has what the Under-Secretary just said tackled the issue raised by the Royal College of Pathologists? It states:
''The Explanatory Notes state that the purpose of Clause 9 is to exempt from the Bill anything done for the functions of a coroner or under his authority. However, the Bill itself goes beyond this by requiring the 'consent of the coroner' before tissue can be removed and stored. This is contrary to Coroners Rules 9 and 12 which actually oblige the pathologist to make provision for the retention of any material which in his opinion bears upon the death. The coroner's role under Rules 9 and 12 is not to grant 'consent' but to stipulate the period of retention.''

Stephen Ladyman: I believe that that statement is based on a misunderstanding. The Royal College of Pathologists believes that there is a conflict between the Bill and coroners rules 9 and 12, under which there is a duty to preserve material that may be relevant to the coroner. That is a misunderstanding. There is no such conflict, and on that basis, I ask the hon. Member for South Cambridgeshire to withdraw his amendment.

Andrew Lansley: I understand and accept the point that was made about amendment No. 25. As far as amendment No. 13 is concerned, I must confess that I was not aware that the phrase the
''purposes of functions of a coroner''
 necessarily limited the provision to the statutory functions of coroners, and that there were non-statutory functions of coroners that had to be protected beyond that. If the Under-Secretary is right, I will withdraw amendment No. 13, and take the alternative tack when talking about the next amendment. I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn.

Andrew Lansley: I beg to move amendment No. 26, in
clause 9, page 8, line 23, at end add— 
 '(3) Where a body or relevant material has been retained and is no longer required for the purposes of functions of a coroner, no activities to which subsections (1), (2) or (3) of section 1 applies, or analysis of DNA, other than excepted purposes under section 47, may be undertaken other than with appropriate or qualifying consent.'.

Andrew Lansley: In a sense we are looking at the other side of the coin now. If all the functions of a coroner are protected, we come to the question of what happens when a body or relevant material is no longer required for the purposes of functions of a coroner. Amendment No. 26 is intended to make it perfectly clear that the coroner cannot go beyond his functions and use his authority under subsection (1) as a substitute for appropriate and qualifying consent. I am talking about going beyond the point where he has a legitimate purpose in mind.
 I may have strayed into a problem in relation to the phrase the 
''purposes of functions of a coroner''.
 We may need to think about that, and express the proposal differently to embrace not only the statutory 
 functions of a coroner, but those activities that are ''contingent on'', ''incidental to'', ''consequent upon'', or ''related to'' them. We will have to think of some terminology. We must maintain the protection that the Under-Secretary talked about in relation to coroners' activities, but at the same time we must emphasise that, when a coroner no longer has a legitimate purpose in mind or an activity that he has to undertake, his authority cannot be used in lieu of consent. In such cases, we must rest on the golden thread, as the Under-Secretary put it, of the appropriate or qualifying consent elsewhere defined. 
 If the Under-Secretary's problem relates to the terminology, 
''purposes of functions of a coroner'',
 and that is why he does not want to accept amendment No. 26, I would be grateful if he would say that he will think about the intention behind the amendment in order to strengthen the presumption that the authority of the coroner cannot extend beyond the coroner's purposes.

Stephen Ladyman: The hon. Gentleman is quite right. As I said on the previous amendment, it is important to protect the coroner's non-statutory duties as well as his statutory duties. We are talking about ensuring that the wider role of the coroner is protected under the Bill. I understand what the hon. Gentleman is trying to achieve. He is trying to ensure that the coroner cannot go beyond his own duties, or the duties we require of him, to override the need to get consent for the use of material.

Andrew Lansley: Or to avoid it.

Stephen Ladyman: Or to avoid it. The hon. Gentleman's amendments are unnecessary because the Bill already achieves their proposed effect. It is precisely what the Bill has been drafted to do. Its approach is to establish that the consent of the deceased or that of someone close to the deceased is always needed for storage and use of bodies and tissue from them, except in particular circumstances. The coroner's authority would last only as long as his functions were required; once his functions have been fulfilled, his authority would lapse. The provision in the Bill requiring someone's consent for storage would then come into effect.

Andrew Lansley: Just to be sure, am I right in thinking that if a coroner were to give his consent for something to be done that was not necessary for his legitimate purposes, or beyond the point where he had a legitimate function in relation to a body, the fact that he gave authority would be ultra vires and the coroner himself would be subject to liability and prosecution under the Act?

Stephen Ladyman: That is correct. The coroner would be acting outside his authority, and therefore anybody who carried out an action based on that authority would be infringing the Act. The Bill is quite clear that the person would be committing a criminal offence if he did not have appropriate consent and carried out an activity that requires it, unless he was absolved from obtaining consent because he was acting under a coroner's authority. It follows that if he were not acting under a coroner's authority because the coroner
 did not possess it, he would be committing an offence. I hope that that is the assurance that the hon. Gentleman needs.

Andrew Lansley: I think that that is the assurance that I am seeking. The Minister and the Committee know that it is not a trivial issue. The retention of the brain of one of my constituents, whose case was described in detail in the Isaacs report, was conducted during a coroner's post mortem. If it were possible for that to be done in the future under the authority of the coroner because the consent provisions in the Bill did not cover it, it would be a serious lapse.

Stephen Ladyman: We must accept that one reason for the retention that the hon. Gentleman mentioned was that the people acting on that occasion were unclear about the legal position. We are making the legal position crystal clear and it will be backed up by appropriate guidance, so I hope that that sort of event will not happen if we leave the Bill as drafted.

Andrew Lansley: We are of one mind as to the purpose of the provision. I wanted only to explore whether we were absolutely clear that the Bill achieved its effect. It is worth remembering that the coroner's purpose is to determine the cause of death. The retention of brains, in the case of my constituent and that of Mrs. Isaacs, did not bear on determining the cause of death. As long as we are absolutely clear—I take it from the Under-Secretary assurance that we are—that such activity would be ultra vires to the coroner's powers, would come under the consent provisions and be subject to prosecution, I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Clause 9 ordered to stand part of the Bill. 
 Further consideration adjourned.—[Joan Ryan.] 
 Adjourned accordingly at six minutes to Five o'clock till Tuesday 3 February at ten minutes past Nine o'clock.